Medical practitioners currently use stabilizing elements to immobilize catheters and tubes within various body lumens, including the gastro-intestinal tract and the biliary duct.
One type of known stabilizing device is a drainage catheter used to drain the kidney or biliary system. These catheters have been developed with so-called pigtail loops at their distal ends to prevent accidental removal from the target drainage site. The pigtail loop is tightened by pulling on the proximal end of a filament, which extends within a lumen through the catheter. The distal end of the filament emerges from the lumen, extends along the outer surface of the catheter, and affixes to the distal tip of the catheter. Pulling on the proximal free end of the filament pulls the distal end of the catheter into a pigtail loop. The pigtail loop stabilizes the catheter during drainage of fluid.
Although well-suited for its intended purpose, these pigtail catheters possess numerous drawbacks. For example, the filament may be prone to breakage or degradation (e.g., drainage fluid may solidify and accumulate on the filament) because the wire is typically disposed within the same lumen as the fluid contents that are being drained. Additionally, the distal portion of the filament is not concealed within the lumen. Rather, it is exposed to the drainage environment. As a result, the distal portion of the filament is also prone to breakage or degradation. Damage of the filament may decrease the capability of the filament to pull the distal end of the catheter into the desired pigtail loop configuration, which can result in the release of the distal end of the loop with the possibility that the catheter is withdrawn from the patient.
Sutures are typically connected to the stabilizing element. Pulling on the suture causes the stabilizing element to immobilize the medical device at a target site. However, these sutures are typically disposed outside of the medical device. Thus, the sutures over time may break or degrade due to the inherent acidic environment within the gastro-intestinal tract and the biliary duct. As a result, conventional stabilizing elements may be prone to failure.
Current stabilizing elements also are problematic because they increase the delivery profile of the catheter, thereby making delivery through relatively narrow body lumens problematic. Even if delivery to the target site is possible, conventional stabilizing elements present the additional problem of not possessing adequate holding strength to sufficiently anchor the catheter against a body wall.
Accordingly, there has not been provided an effective anchoring assembly for stabilizing and immobilizing a catheter against a body lumen.